Clinical trial · Observational
Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims : * to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting * to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anticoagulants and Thrombotic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Rivaroxaban
- description
- Cancer patients treated with rivaroxaban
- interventionNames
- Other: Monitoring
- label
- Apixaban
- description
- Cancer patients treated with apixaban
- interventionNames
- Other: Monitoring
Primary outcomes (1)
- measure
- Population pharmacokinetic evaluation
- timeFrame
- 3 years
- description
- Estimated area under the curve (AUC) of each of the 2 drugs studied
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female subjects with age ≥ 18 years * Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 6 months prior to inclusion * Confirmed symptomatic or venous thromboembolism or confirmed atrial fibrillation * Patients affiliated with a health insurance system * Able to provide written informed consent. Exclusion Criteria: * Age \<18 years * Pregnancy or breastfeeding * Patients not affiliated with a health insurance system * Patient subject to a measure of protection * Legally protected adults * Life expectancy \< 3 months
References
Publications (0)
Data not yet available